jRCT2031190137进行中（未招募）不适用
Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial
未提供0 个研究点目标入组 12 人开始时间: 2019年12月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 主要终点
- Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 75age old not（—）
- 性别
- All
入选标准
- •Outpatients aged >=20 and < 75 years old on the day of informed consent (IC)
- •Patients with CIPO (designated intractable disease 99) at enrollment, meeting all the criteria specified in (1) to (7) of the CIPO Diagnostic Criteria issued in 2014 by the MHLW Research Group, or patients with CIPO, secondary to systemic scleroderma, meeting all the same criteria specified in (1) to (6)
- •Patients with GSS, a 4 Likert scale of abdominal bloating symptom level from 0 to 3, of 2 or 3 at the time of IC acquisition and enrollment.
排除标准
- •Patients with malignant diseases (excluding those with stable symptoms and not requiring aggressive treatments such as chemotherapy and/or surgical therapy)
- •Patients with psychiatric diseases (excluding those with stable symptoms, and judged appropriate for efficacy assessment without any concern by the investigator or coinvestigators)
- •Patients with severe diabetes within 5 weeks before enrollment (HbA1c > 10%)
- •Patients with gastrostomy (including percutaneous sendoscopic gastro-jejunostomy, PEG-J), enterostomy, or colostomy for decompression
- •Patients who underwent intestinal decompression therapy not associated with surgical procedures (trans-nasal ileus tube) within 4weeks before enrollment
- •Patients who used antimicrobials, antiparasitics or antifungals (excluding topical use) within 4 weeks before enrollment
- •Patients who have changed the doses of the following concomitant medications within 4 weeks before enrollment: mosapride, daikenchuto, metoclopramide, acotiamide
- •Patients with severe liver dysfunction within 5 weeks before enrollment (who meet one or more of the following criteria: AST >= 5 times the upper limit of the common reference value specified in the Japanese Committee for Clinical Laboratory Standards (JCCLS), ALT>= 5 times the upper limit of the common reference value specified in JCCLS, total bilirubin >= 3 times the upper limit of the common reference value specified in JCCLS, decompensated liver cirrhosis, or jaundice)
- •Patients who are pregnant, breastfeeding, possibly pregnant, or with desire to get pregnant
- •Patients with a previous history of hypersensitivity to any investigational product ingredients
- •Patients with active tuberculosis
- •Patients who participated in other clinical trial (including a trial with an investigational product) and received an intervention with a test drug within 12 weeks before this enrollment
- •Patients judged inappropriate for enrollment in the trial by the investigator or coinvestigator
结局指标
主要结局
Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)
时间窗: at the end of administration (4 weeks)
Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)
Improvement ratio (%) in Gastrointestinal (GI) symptoms score
Improvement ratio (%) in Gastrointestinal (GI) symptoms score
次要结局
- Changes of each score in Global Symptomatic Score other than abdominal bloating score (additional symptoms)
- Changes of the "good" ratio (%) in gastrointestinal symptoms score
- Changes of the improvement ratio (%) in General health condition (symptoms) score
- Changes of Serum endotoxin activity
- Changes of the improvement ratio (%) in gastrointestinal symptoms score
- Changes of the improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)
- Changes of abdominal bloating score in Global Symptomatic Score (GSS)
- Changes of each score in Global Symptomatic Score other than abdominal bloating score
- Changes of the "good" ratio (%) in General health condition (symptoms) score
- Changes of the improvement ratio (%) in patient satisfaction score
- Changes of Short Form (SF)-8 health survey score
- Changes of small intestinal volume measured by abdominal CT scan
- Fecal test (intestinal flora)
- Incidence of adverse events
- Changes from baseline of nutritional assessment parameters
- Changes from baseline of laboratory test parameters
- Small intestinal bacterial overgrowth (SIBO) in a glucose-hydrogen breath test
研究者
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